Study protocol for JCOG1807C (DEEP OCEAN): a interventional prospective trial to evaluate the efficacy and safety of durvalumab before and after operation or durvalumab as maintenance therapy after chemoradiotherapy against superior sulcus non-small cell lung cancer

Background Superior sulcus tumours (SSTs) are relatively uncommon and one of the most intractable lung cancers among non-small cell lung cancer (NSCLC). We planned a multicenter, single-arm confirmatory trial of new multidisciplinary treatment using immune-checkpoint inhibitor. The aim is to evaluate the safety and efficacy of new multidisciplinary treatment with perioperative durvalumab after chemoradiotherapy (CRT). Methods The primary endpoint is 3-year overall survival. Patients receive induction CRT with sequential two courses of durvalumab, followed by surgical resection for resectable SST. The regimen for CRT is two courses of cisplatin and S-1, and concurrent radiotherapy (66 Gy/33 Fr). After surgery, 22 courses of post-operative durvalumab therapy are administered. For unresectable SST, an additional 22 courses of durvalumab are administered after induction durvalumab. Results In two cases as a safety cohort, the safety of intervention treatment up to 30 days after surgery was examined, and there were no special safety signals. Patient enrollment has now resumed in the main cohort. Conclusions The results of this study may contribute to the establishment of a new standard of care for SST, which is an intractable NSCLC.

Association of Upper Lip Morphology Characteristics with Sagittal and Vertical Skeletal Patterns: A Cross Sectional Study

Background: Upper lip morphology is essential in diagnosis and treatment of orthodontics and orthognathic surgery. This study is aimed to evaluate the association between upper lip characteristics (ULCs) and skeletal patterns (SPs). Methods: 2079 patients were involved and grouped by sagittal and vertical. Class I, II, and III were identified by ANB angle, while normodivergent, hyperdivergent, and hypodivergent were identified by Facial Height Index and Sum of Angles. ULCs were evaluated by superior sulcus depth, nasolabial angle, upper lip length, basic upper lip thickness, and upper lip thickness. Confounders including demography, malocclusion, upper incisors, and upper lips were adjusted by multivariate linear regression to identify the association between ULCs and SPs. Group differences were evaluated with analysis of variance and Chi-square test. Results: The mean value of ULCs and prevalence of SPs were explored in the Western China population. ULCs were significantly different in various sagittal, vertical, and combined SPs. Superior sulcus depth was negatively related to Class II, and positively related to Class III and the hypodivergent pattern after adjusted by confounders. Conclusion: ULCs significantly varied among different SPs, while only superior sulcus depth was independently associated with SPs, indicating superior sulcus depth is the only ULC that might be significantly corrected by intervention of skeletal growth.

Hyaluronic acid injections in post-enucleation or evisceration socket syndrome: a case series

Background One of the primary goals of enucleation and evisceration surgery is the restoration of an adequate orbital volume through the use of appropriately sized alloplastic or autogenous tissues. In patients inadequately treated, post-enucleation or evisceration socket syndrome occurs. Fillers are an ideal alternative for eyelid and eyebrow arcade volume enhancement since their injection is easily performed in an outpatient setting avoiding several complications. The aim of this study is to report the use of hyaluronic acid (HA) fillers to treat volume deficits of the upper and lower eyelids, projecting the brow arcade and reducing the asymmetry. Methods Thirteen patients (2 male, 11 female, mean age 32.7 years) were treated from June 2012 to May 2020. Non-surgical treatment by HA filler injection for aesthetic rehabilitation of deep superior sulcus, inferior tear trough deformity, and scleral show was performed. Results No complications as orbital-ache and/or vasovagal response were reported during the injections. Minor complications such as light swelling at the site of injection, self-resolved within 2 days, were recorded. Stable results were observed at follow-ups. In two cases, two successive treatments were required at 3 and 6 years from the first injection. Conclusions Hyaluronic acid fillers offer a versatile and safe method for replacing soft tissue lost from the upper eyelid/brow complex in cases of post-enucleation or evisceration socket syndrome. Level of evidence: Level IV, therapeutic study.